FDA Inspection 912250 — Boiron
The FDA completed an inspection of Boiron on January 15, 2015 in Messimy. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 15, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Messimy (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |